A Pilot Program to Personalize Care by Integrating Traditional and Complementary Medicine for Women With Ovarian Cancer

Trial Information

A Pilot Program to Personalize Care by Integrating Traditional and Complementary Medicine for Women With Ovarian Cancer

The study will be offered to women with ovarian cancer who are receiving care at the
Gynecologic Oncology Clinic at H. Lee Moffitt Cancer Center. Prospective candidates,
identified via chart review, will receive a mailing that describes and invites them to be
screened for eligibility. Potential participants seen in the clinic will also be approached
and invited to participate.

The informed consent process and pretesting will take place in the clinic, with exceptions
made as needed for women who prefer to complete documents at home.

The intervention, which will consist of four educational CAM sessions, will be held on site
in a private room at Moffitt Cancer Center. Immediately before and after each session, we
will administer a brief on-site pre- and post-test. Upon completion of the intervention,
participants will be asked to complete a post-test on site or at home, depending on their
preference. Follow-up telephone calls will be made to the participants 4 weeks and again at
8 weeks after the last session.

Pre- and post-test measures will focus on quality of life, prior use of CAM therapies, topic
preferences, knowledge gained from the presentations, changed intentions and behaviors
associated with CAM, and satisfaction with the program.

Inclusion Criteria:

- A diagnosis of ovarian cancer

- An Eastern Cooperative Oncology Group (ECOG) score of 2 or less with a life
expectancy of at least 12 months

- A patient being treated by a gynecologic oncologist in the Center for Women's
Oncology

- Ability to read, understand, and sign the informed consent form

- Ability to read, write and understand English, which will be the language used in the
materials and oral presentations

- Willingness to complete pre-test and post-test questionnaires

- Willingness to complete brief questionnaires at each session

- Willingness to participate in two follow-up telephone interviews at 4 and 8 weeks
after the final session

- Willingness to participate in four sessions that take place at Moffitt Cancer Center

- Access to transportation, with the ability to travel to and from Moffitt to
participate in the sessions

Type of Study:

Study Design:

Outcome Measure:

Number of Participants Interested in Complementary and Alternative Medicines (CAM)

Outcome Description:

Aim 1, proportions of participants who attend the education sessions (with 95% confidence intervals) will be calculated for each of the 5 CAM therapies. Mean (along with SD) score will be calculated for each therapy.

Outcome Time Frame:

Average of 18 Weeks

Safety Issue:

No

Principal Investigator

Robert Wenham, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-15221

NCT ID:

NCT01419210

Start Date:

January 2010

Completion Date:

September 2013

Related Keywords:

Ovarian Cancer

Complementary Medicine

Traditional Medicine

Ovarian Neoplasms

Name

Location

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